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Docosanol

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Active ingredient
Docosanol 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
July 20, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Docosanol 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
July 20, 2023
Manufacturer
H2-Pharma, LLC
Registration number
ANDA212385
NDC root
61269-989
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Docosanol is a topical cream that contains 10% of the active ingredient and is specifically designed to treat cold sores and fever blisters on the face or lips. It works by shortening the healing time and reducing the duration of symptoms such as tingling, pain, burning, and itching. Notably, it is the only FDA-approved medication that has been shown to effectively shorten the healing time of these sores.

This cream is available in a convenient pump and is comparable to the active ingredient found in Abreva®. If you are looking for relief from cold sores, Docosanol may be a helpful option to consider.

Uses

If you’re dealing with cold sores or fever blisters on your face or lips, this medication can help. It not only treats these uncomfortable sores but also shortens the healing time and reduces the duration of symptoms such as tingling, pain, burning, and itching.

By using this treatment, you can expect relief from the discomfort associated with cold sores, allowing you to feel more like yourself again.

Dosage and Administration

Before using the cream, make sure to wash your hands thoroughly. When you notice the first signs of a cold sore or fever blister, such as a tingling sensation, apply the cream directly to the affected area on your face or lips. It's important to start treatment as early as possible for the best results. Gently rub the cream in until it is completely absorbed.

For adults and children aged 12 years and older, you should apply the cream five times a day until the cold sore is healed. If you are considering using this cream for a child under 12, please consult a doctor first for guidance. Remember to wash your hands again after applying the cream to avoid spreading the virus.

What to Avoid

It's important to be aware of certain precautions when using this product. First and foremost, do not use it if you are allergic to any of its ingredients, as this could lead to serious reactions. Additionally, avoid applying the product in or near your eyes and do not use it directly inside your mouth. Sharing this product with others is also discouraged, as it can spread infections.

By following these guidelines, you can help ensure your safety and the effectiveness of the treatment. If you have any concerns or questions about using this product, please consult with a healthcare professional.

Side Effects

You should be aware that this product can cause a severe allergic reaction in some individuals. Symptoms of such a reaction may include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you have a known allergy to any ingredient in this product, it is important not to use it.

If your cold sore worsens or does not heal within 10 days, you should stop using the product and consult a doctor. Always prioritize your health and safety when using any medication.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction. If you experience symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, or a rash, stop using the product immediately and seek medical help. Do not use this product if you are allergic to any of its ingredients.

If your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor. Additionally, if the product is swallowed, seek emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 right away.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

There are no specific warnings or precautions regarding the use of docosanol during pregnancy, and the drug insert does not indicate whether it is contraindicated (not recommended) for pregnant individuals or if there are any risks to the fetus. Additionally, there is no information provided about safety concerns related to using docosanol while pregnant.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including docosanol, to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of docosanol cream, you can feel reassured as there are no specific warnings or recommendations regarding its use for nursing mothers. Additionally, the information available does not indicate any risk of the cream being passed into breast milk or affecting your infant. Always consult with your healthcare provider if you have any concerns or questions about using new products while breastfeeding.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this cream. For children aged 12 and older, you should wash your hands before and after applying the cream. Apply it to the affected area on the face or lips as soon as you notice the first signs of a cold sore or fever blister, such as a tingling sensation. Starting treatment early can lead to better results. Make sure to rub the cream in gently and completely, using it five times a day until the area is healed.

Geriatric Use

While there is no specific information about the use of Docosanol cream in older adults, it’s important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before starting this treatment. They can help ensure that it is appropriate for your needs and discuss any potential risks or considerations based on your health status. Always prioritize open communication with your doctor, especially when it comes to managing your health as you age.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°-25°C (68°-77°F). It's important to keep it in this range to maintain its effectiveness. Please avoid freezing the product, as this can damage it and affect its safety.

When handling the product, make sure to do so in a clean environment to prevent contamination. Always follow any additional safety instructions provided with the product to ensure safe and effective use.

Additional Information

You should apply the topical medication five times a day until the cold sore is healed. If your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor. Additionally, if the medication is accidentally swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Docosanol used for?

Docosanol is a 10% cream used for the treatment of cold sores and fever blisters on the face or lips.

How does Docosanol work?

Docosanol shortens the healing time and duration of symptoms such as tingling, pain, burning, and itching associated with cold sores.

Who can use Docosanol?

Docosanol is intended for adults and children 12 years or older. Children under 12 should ask a doctor before use.

How should I apply Docosanol?

Wash your hands before and after applying the cream to the affected area at the first sign of a cold sore. Rub it in gently and use it 5 times a day until healed.

Are there any contraindications for using Docosanol?

Do not use Docosanol if you are allergic to any ingredient in the product.

What should I do if I experience an allergic reaction?

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop using Docosanol and seek medical help immediately.

What should I do if my cold sore does not heal?

If your cold sore worsens or does not heal within 10 days, stop use and consult a doctor.

Can I use Docosanol near my eyes or inside my mouth?

No, you should not use Docosanol in or near the eyes or apply it directly inside your mouth.

How should I store Docosanol?

Store Docosanol at 20°-25°C (68°-77°F) and do not freeze.

What should I do if I accidentally swallow Docosanol?

If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

Packaging Info

Below are the non-prescription pack sizes of Docosanol. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Docosanol.
Details

Drug Information (PDF)

This file contains official product information for Docosanol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Docosanol is a 10% topical cream indicated for the treatment of cold sores and fever blisters. It is the only FDA-approved medication designed to shorten healing time. The product is packaged in a portable and convenient pump, allowing for easy application. Each container has a net weight of 2 grams (0.07 ounces). The National Drug Code (NDC) for this formulation is 61269-989-37, and it is manufactured by H² pharma.

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters on the face or lips. It is effective in shortening the healing time and reducing the duration of associated symptoms, including tingling, pain, burning, and itching.

Dosage and Administration

Healthcare professionals are advised to instruct patients to wash their hands thoroughly before and after applying the cream. For adults and children aged 12 years and older, the cream should be applied to the affected area on the face or lips at the first sign of a cold sore or fever blister, such as a tingling sensation. Early treatment is crucial for optimal results. The cream should be rubbed in gently but completely, and it is recommended to apply the cream five times a day until the lesion is healed.

For children under 12 years of age, it is essential to consult a physician before use.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Additionally, the product should not be applied in or near the eyes, nor should it be used directly inside the mouth. Sharing this product with others is also contraindicated, as it may facilitate the spread of infection.

Warnings and Precautions

This product has the potential to induce a severe allergic reaction. Healthcare professionals should be vigilant for symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product is intended for external use only. It is contraindicated in individuals with a known allergy to any of its ingredients.

Patients should be advised to stop using the product and consult a healthcare provider if their cold sore worsens or fails to heal within 10 days.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients may experience a range of adverse reactions associated with this product. A severe allergic reaction is a significant concern, with symptoms that may include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. Due to the potential for such reactions, individuals who are allergic to any ingredient in this product are advised not to use it.

In clinical practice, it is important for patients to monitor their condition closely. If a cold sore worsens or does not heal within 10 days, patients should discontinue use and consult a healthcare professional for further evaluation and guidance.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Docosanol. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Docosanol.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents aged 12 years and older, it is recommended to wash hands before and after applying the cream. The cream should be applied to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Early treatment is essential for optimal results. The cream should be gently but completely rubbed in and applied five times a day until healing is achieved.

Geriatric Use

Elderly patients may use Docosanol cream; however, the prescribing information does not provide specific details regarding geriatric use, dosage adjustments, safety concerns, or special precautions for this population. As such, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential comorbidities. Monitoring for efficacy and any adverse effects is advisable, given the lack of targeted data for elderly patients.

Pregnancy

There are no specific warnings, precautions, or dosage modifications regarding the use of docosanol during pregnancy mentioned in the prescribing information. The insert does not indicate whether docosanol is contraindicated in pregnancy or if there are any risks to the fetus. Additionally, no information is provided about safety concerns related to the use of docosanol during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of docosanol cream in lactating mothers. Additionally, there is no information available concerning the potential for excretion of docosanol in breast milk or any associated risks to breastfed infants during the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed not to use the product if they are allergic to any of its ingredients. It is important to counsel patients to stop using the product and consult a doctor if their cold sore worsens or does not heal within 10 days.

When using this product, patients should apply it only to the affected areas and avoid contact with the eyes. They should be cautioned against applying the product directly inside their mouth. Additionally, patients must be advised not to share this product with anyone, as this may facilitate the spread of infection.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Freezing is not permitted, as it may compromise the integrity of the product. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment to maintain its efficacy. Special handling needs should be observed to prevent any damage or degradation during storage.

Additional Clinical Information

The product is administered topically and should be applied five times a day until the lesion is healed. Clinicians should advise patients to discontinue use and consult a healthcare professional if the cold sore worsens or does not heal within 10 days. In the event of accidental ingestion, patients are instructed to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Docosanol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Docosanol, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.